POSTOVAL®tablets
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
POSTOVAL®tablets
COMPOSITION:
Each 28 - day blister pack contains:
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11 white coated tablets each with 2 mg oestradiol valerate; |
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10 orange coated tablets each with 2 mg oestradiol valerate and 0,5 mg norgestrel; |
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7 red coated inactive tablets. |
The orange tablets contain TARTRAZINE.
PHARMACOLOGICAL CLASSIFICATION:
Category A, 21.8.2. Progesterones with oestrogens
PHARMACOLOGICAL ACTION:
Oestradiol valerate is a fatty acid ester of the naturally occurring hormone, oestradiol, and has similar actions.
Norgestrel is a progestogen with actions similar to those of progesterone.
Cyclical therapy with POSTOVAL in the perimenopausal/postmenopausal state provides hormonal replacement. This aids in relieving vasomotor and autonomic nervous system symptoms caused by oestrogen decline, as well as depression, irritability and anxiety associated with declining ovarian function.
INDICATIONS:
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1. |
The regulation of cycle disturbances, such as periodicity, duration and intensity of menstrual flow. |
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2. |
Relief of vasomotor and autonomic nervous system symptoms caused by oestrogen decline, as well as depression, irritability and anxiety associated with perimenopausal/postmenopausal state. |
POSTOVAL IS NOT A CONTRACEPTIVE.
CONTRA-INDICATIONS:
Severe migraine, cholestatic jaundice.
Medication should be discontinued immediately if migraine becomes focal or there is a loss of vision or if there is an onset of unexplained chest pain. Markedly impaired liver function.
Benign or malignant liver tumour, which developed during the use of oestrogen-containing products. Dubin-Johnson syndrome.
Rotor syndrome.
Known or suspected breast, endometrial or genital carcinoma.
Known or suspected hormone-dependent neoplasia.
Undiagnosed abnormal vaginal bleeding.
Congenital disturbances of lipid metabolism.
Otosclerosis with deterioration during pregnancy.
Known or suspected pregnancy.
Cerebral vascular or coronary artery disease.
Thrombophlebitis or thromboembolic disorders, or patients with a history of these disorders.
Relative contra-indications include a history of diabetes, epilepsy, asthma, hypertension, depression, porphyria or states in which fluid retention occurs.
WARNINGS:
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1. |
Carcinoma: |
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(a) |
There are reports that oestrogens may increase the risk of carcinoma of the endometrium in humans. |
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(b) |
There is need for caution in prescribing oestrogens for women with a family history of breast disease or women who have breast nodules or fibrocystic disease of the breasts. |
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Cigarette smoking: |
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Cigarette smoking increases the risk of serious cardiovascular side-effects from the use of oral contraceptives. The risk increases with age, and with heavy smoking (15 or more cigarettes per day) is quite marked in women over 35 years of age. Women who use POSTOVAL should be strongly advised not to smoke. |
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Gallbladder disease: |
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A two to three fold increase in the risk of gallbladder disease in women receiving postmenopausal oestrogens has been reported. |
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4. |
Elevated blood pressure: |
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Increased blood pressure may occur with the use of oestrogens in the menopause, and blood pressure should be monitored routinely. |
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5. |
Glucose tolerance: |
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A decrease in glucose tolerance has been observed in patients on oestrogen-containing oral contraceptives. For this reason, diabetic patients should be carefully observed while receiving POSTOVAL. |
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6. |
Growth of foci of endometriosis may be promoted. |
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The orange tablets of this product contains F D and C Yellow No 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who have aspirin-sensitivity. |
DOSAGE AND DIRECTIONS FOR USE:
If menstrual cycles are still occurring:
Start by taking the tablet in the GREEN AREA of the package, marked with the appropriate day of the week, on the first day of the menstrual cycle (i.e. the first day of bleeding).
If menstrual cycles are no longer occurring:
Start immediately by taking the tablet in the GREEN AREA of the package marked with the appropriate day of the week.
Then take one tablet each day, as nearly as possible at the same time each day, following the arrows until all tablets are finished. The day after the last tablet has been taken, a new pack must be started, by taking the tablet in the GREEN AREA of the new pack indicated with the appropriate day of the week.
Withdrawal bleeding will occur two to four days after taking the last orange tablet. If the patient forgets to take a tablet she should continue taking the tablets as prescribed omitting the missed tablet. Intermenstrual bleeding may occur as a result of a missed tablet.
If tolerance to POSTOVAL occurs, the patient must stop medication.
Medication must be immediately discontinued in cases of:
(a) jaundice or thrombosis
(b) pregnancy
Duration of therapy depends on the severity of the functional disturbance.
POSTOVAL is not a contraceptive. If withdrawal bleeding fails to occur, pregnancy should be ruled out before medication is continued.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
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The incidence of diseases of the circulatory system of women using combined oestrogen/progestogen preparations is significantly greater than those of controls, and the mortality is slightly increased. Coronary thrombosis, cerebrovascular accidents and venous thrombosis, are more likely to occur in women aged 35 years or over, particularly if they have used the combined oestrogen-progestogen preparation for longer than five years, if they smoke, if they are obese or if they are hypertensive. Additional risk factors are diabetes, hypercholesterolaemia and familial hyperlipoproteinaemia. |
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2. |
Hypertension may occur in association with the use of combined oestrogen-progestogen preparations. Regular blood-pressure checks, including a pretreatment level, are advisable. |
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3. |
Mood changes, mass gain, skin pigmentation, vaginal candidiasis, gall bladder disease, gastrointestinal irritation and fluid retention may occur. |
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4. |
Case reports have been published of benign hepatic tumours in women on combined oestrogen-progestogen preparations for a prolonged time, but a causal relationship has not been established. The preparation should be discontinued if persistent upper abdominal pain develops. |
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5. |
Interaction with other medicines and efficacy: |
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the efficacy of combined oestrogen/progestogen preparations may be decreased when they are administered concomitantly with other medicines such as the anti-epileptic agents and rifampicin. |
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With vomiting or diarrhoea, the absorption of combined oestrogen-progestogen preparations may be diminished. |
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Effects on laboratory tests: |
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Combined oestrogen-progestogen preparations may interfere with some laboratory estimations, in particular hormones, glucose tolerance, thyroid function, blood coagulation, serum triglycerides and liver function tests. |
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Surgery is more likely to be associated with an increased incidence of thrombotic side-effects. Adequate precautions should be taken. |
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An increase in the incidence of carcinoma of the uterus has been reported with continuous use of oestrogens in postmenopausal women. |
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Any undiagnosed uterine bleeding before or during treatment is an indication for establishing a definite diagnosis to rule out genital malignancy. |
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The administration of POSTOVAL to perimenopausal women does not eliminate the necessity for contraception. |
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Additional adverse reactions reported with oestrogenic or progestogenic therapy: |
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Genito-urinary System: |
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Breakthrouqh bleeding, spotting, change in menstrual flow, dysmenorrhoea; premenstrual like syndrome; amenorrhoea during and after treatment; increase in size of uterine fibromyomata; change in cervical erosion and in degree of cervical secretion; cystitis like syndrome |
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Breasts: |
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Tenderness, enlargement, secretion. |
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Gastro intestinal: |
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Nausea, vomiting, abdominal cramps. |
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Eyes: |
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Steepening of the corneal curvature, intolerance to contact lenses. |
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Central Nervous System: |
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Headache, migraine, dizziness, mental depression; chorea. |
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Miscellaneous: |
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Changes in libido, loss of scalp hair, hirsutism. |
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In the menopause, it is recommended that all candidates for hormone replacement therapy undergo a complete physical examination, including endometrial assessment, at the time of the initial visit. This applies particularly to patients who may have had a history of irregular bleeding or endometrial hyperplasia during their reproductive years. Should a hyperplastic condition be found, either at the initial examination or during a follow-up visit, the patient should be given a progestogen for at least 3 to 6 weeks to check if the endometrium will revert to normal. If it does, POSTOVAL therapy can be instituted. |
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Patients with a past history of jaundice during pregnancy have an increased risk of recurrence of jaundice while receiving oestrogen-containing replacement therapy. If jaundice develops in any patient receiving POSTOVAL, the medication should be discontinued while the cause is in investigated. |
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Use during pregnancy: |
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OESTROGENS AND PROGESTINS SHOULD NOT BE USED DURING PREGNANCY. POSTOVAL has not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the foetus. |
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.
IDENTIFICATION:
11 large white coated tablets;
10 large orange coated tablets, and
7 red coated tablets in a blister-type package
PRESENTATION:
POSTOVAL is available in blister packs of 28 tablets (21 active and 7 inert tablets).
STORAGE DIRECTIONS:
Store in a cool (below 25°C), dry place.
Keep out of reach of children.
REGISTRATION NUMBER:
K/21.8.2/289
NAME AND BUSINESS ADDRESS OF APPLICANT:
AKROMED PRODUCTS (PTY) LTD.
Electron Avenue, ISANDO 1600
Trademark and product, under licence from
WYETH-AYERST LABORATORIES, U.S.A.
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 NOVEMBER, 1989
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